The term “urinary incontinence” refers to involuntary leakage of urine from the body in an uncontrolled manner. One cause of incontinence is increased mobility of the bladder outlet, referred to as “bladder outlet hypermobility,” whereby the bladder and proximal urethra do not maintain their normal anatomic positions during transient periods of increased bladder pressure. In addition, there is a small region of circular muscle surrounding the middle portion of the urethra in the female called the “urethral sphincter,” which also participates in the controlled release of urine from the bladder. If the bladder outlet becomes too mobile and/or if the urinary sphincter or any other part of the urinary system malfunctions, the result may be urinary incontinence.
Urinary incontinence can generally be characterized into two types, one of which is called “stress incontinence” and the other “urge incontinence.” Stress incontinence refers to involuntary loss of urine during coughing, laughing, sneezing, jogging or other physical activity that causes a sufficient increase in intra-abdominal pressure. Urge incontinence refers to the involuntary loss of urine due to unwanted bladder contraction that may be associated with an almost uncontrollable desire to urinate. “Mixed incontinence” refers to a combination of both urge and stress incontinence.
Heretofore, many different types of treatment have been utilized to treat female urinary incontinence including surgical and non-surgical procedures including the precisely-controlled injection, i.e., under cystoscopic visualization, of collagen or other material into the tissue surrounding or adjacent to the bladder outlet. In addition, drug therapy also has been utilized, for example, drugs to treat the detrusor muscle, which is the bladder wall muscle responsible for contracting and emptying the bladder. All of these procedures and therapies have drawbacks, are relatively expensive and, in the case of injections, require the equipment and training necessary to perform cystoscopic visualization of the urethra and bladder outlet. There is therefore a need for a new and improved apparatus and method for treatment of female urinary incontinence.
In view of the drawbacks of previously-known devices, it would be desirable to provide apparatus and methods for treating female urinary incontinence by injecting a bulking agent into a “potential space,” defined herein as the space that can be formed at the interface between the mucosal and submucosal layers of the urethral wall and/or bladder outlet, so that the bulking agent effectively induces localized narrowing of the urethral lumen and/or bladder outlet.
It further would be desirable to provide apparatus and methods for treating female urinary incontinence that allow a physician to inject a bulking agent into the potential space without the need for a cystoscopic visualization device, e.g., a cystoscope.
It still further would be desirable to provide apparatus and methods for treating female urinary incontinence by techniques that do not require external surgical incisions and do not result in external scarring.